
4www.humancaregroup.com
Diana II MLA Service Manual
Human Care is an ISO 13485:2016 cered
Swedish medical device company. The Quality
Management System is in compliance with US
21 CFR part 820.
The product is CE marked in accordance with EU
Direcve 93/42/EEC (MDD) and/or EU Regula-
on 2017/745 (MDR), as class I medical device.
The CE mark is on the product.
This product has been tested in accordance
with ISO 10535.
Compliances and Standards
Useful informaon
a) Service manual
The service manual is created for technicians
involved in servicing of Diana II MLA mobile li.
Safe performance of mobile li service proce-
dures requires experience, technical skills and
general knowledge of safety rules.
This manual uses warnings and cauons to pay
special aenon to service procedures.
Warning – this informaon tells us about the
possibility of safety risk of technician
and user.
Cauon – this informaon tells us about acons
that can cause potenal damage of the
li.
b) Diana II MLA installaon and operang
For installaon and operaon of the li, see the
user manual.
c) Service of Diana II MLA mobile li
The service can be only made by Human Care’s
authorized service team or authorized units by
Human Care.
Human Care shall bear no responsibility for the
consequences of repairs or modicaons that
have been done by unauthorized personnel and
for the use of non-original replacement parts
dedicated by Human Care for mobile li.
d) Service documentaon
Service documentaon and service repair
document are available on a website accessible
for authorized service.
e) Safety precauons
Mobile li design provides maximum of safety
Safety of the device are ensured by safety stan-
dards IEC60601-1.
Read these cauons carefully before
start servicing!
Note - do not perform service repairs
and funconal tesng when the client is
on the device.
f) Addional informaon
In case of any problems with mobile li contact
the intermediary or manufacturer’s service.
Service contact details:
HUMAN CARE SWEDEN (HQ)
Årstaängsvägen 21B
117 43 Stockholm
Phone: +46 8 665 35 00
Fax: +46 8 665 35 10
Email: info.se@humancaregroup.com